FDA.reportPublic FDA data

A.T.S.® Tourniquet System

Primary DI
00889024378469
Brand
A.T.S.® Tourniquet System
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
60-1812-101-00
Catalog number
60-1812-101-00
Device description
Dual Hose w/CPC Connectors
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCYTourniquet, Pneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024378469PackageGS110In Commercial Distribution
00889024381162PackageGS12In Commercial Distribution
00889024367173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024378469008890243784698890243784690889024378469
00889024381162008890243811628890243811620889024381162
00889024367173008890243671738890243671730889024367173

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic tourniquet systemA device assembly intended to occlude the blood flow and to obtain a bloodless field during limb surgery or amputation. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to inflate the cuff, and a control unit, i.e., a pressure indicator and regulator. By using a double cuff and a manual switching or automatic valve, the pressure point is regularly changed to avoid tissue damage or necrosis. The device will also typically include a timer or elapsed-time meter. It may also be used in combination with intravenous local anaesthesia to limit the area affected by the anaesthesia.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
137354267
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024616325Stablecut®XOXCEMTD3PKXOXCEMTD3PK2024-04-09
00889024616332Stablecut®XOXCMTLS3PKXOXCMTLS3PK2024-04-09
00889024647497Stablecut®11-353811-35382023-02-23
00889024647503Stablecut®11-353911-35392023-02-23
00889024647510Stablecut®11-354011-35402023-02-23
00889024647527Stablecut®11-354111-35412023-02-23
00889024647534Stablecut®11-354211-35422023-02-23
00889024647541Stablecut®11-354311-35432023-02-23
00889024647558Stablecut®11-360711-36072023-02-23
00889024647565Stablecut®11-360811-36082023-02-23
00889024647589Stablecut®11-377111-37712023-02-23
00889024647596Stablecut®5061095061092023-02-23
00889024647602Stablecut®5061115061112023-02-23
00889024647619Stablecut®5061425061422023-02-23
00889024647626Stablecut®5061405061402023-02-23
00889024647633Stablecut®5061415061412023-02-23
00889024647640Stablecut® Vanguard™32-70036932-7003692023-02-23
00880304537880Stablecut®5061135061132022-10-03
00880304542464Stablecut®5061145061142022-10-03
00889024493254Stablecut®10070100CR110-0701-00C-R12019-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M99592200250BFR3PTS BFR Tourniquet Instrument & Throwing Cuff Set Delfi Medical Innovations IncKCY2026-01-14
M99597580018L1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M99597580018R1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M99597580021R1BFR Throwing Cuff, Reusable Delfi Medical Innovations IncKCY2026-01-14
M995995000181Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000241Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000301Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000341Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995995000421Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000181Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000241Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000301Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
M995996000341Adaptive Cylindrical Cuff, Limited Reuse Delfi Medical Innovations IncKCY2026-01-08
08809802646971DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
08809802646988DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
08809802646995DTS-3000DAESUNG MAREF CO.,LTD.KCY2025-12-19
M99592500002BFR1PTS for BFR Generation 3 - Dual Channel SystemDelfi Medical Innovations IncKCY2025-06-17
16976514770009Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770016Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770023Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770030Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770047Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770054Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770061Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770078Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770085Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770092Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770108Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770115Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23
16976514770122Disposable Tourniquet CuffZhejiang Longyou Lande Medical Technology Co., Ltd.KCY2025-05-23