FDA.reportPublic FDA data

Key Surgical Plastic Instruments

Primary DI
00849771041092
Brand
Key Surgical Plastic Instruments
Company
KEY SURGICAL, INC.
Model
KS-538-50
Device description
Plastic Instruments, Tube Clamp, 4.5", green
Published
2020-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXDClamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849771027829PrimaryGS10
00849771041092Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771027829008497710278298497710278290849771027829
00849771041092008497710410928497710410920849771041092

GMDN Terms#

Term, Definition table
TermDefinition
Towel clampA surgical instrument designed to hold together surgical towels and/or drapes and/or other devices, e.g., cables/leads that need securing to the site of intervention, e.g., the towels/drapes surrounding or covering the patient/operating table. It is typically made of high-grade stainless steel and can have a variety sizes and designs, e.g., it can have two blades joined at their midpoint that have ring handles at the proximal end, or it may be a single alpha-shaped part joined at the proximal end, whilst the working end may be sharply-pointed, blunted, fenestrated or have various shaped gripping jaws. It is commonly known as a towel clamp, -forceps, or a -clip. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800.541.7995regulatory@keysurgical.com
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags#

DUNS number
604056226
Device count
50
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771052159NAES50ES502023-01-26
00849771048237NAK-Wire and Steinmann Pin DispenserKI710172025-08-11
00849771049036NAK-Wires and Steinmann PinsKI711312025-08-11
00849771049289NAK-Wires and Steinmann PinsKI711852025-08-11
00849771049500NAK-Wires and Steinmann PinsKI712532025-08-11
00849771048169NAK-Wire and Steinmann Pin DispensersKI710022025-04-30
00849771049012NAK-Wires and Steinmann PinsKI711242025-04-30
00849771049128NAK-Wires and Steinmann PinsKI711612025-04-30
60849771050416Electro LubeEL101EL1012025-04-24
00849771046356K-Wire and Steinmann Pin DispensersKI71042KI710422025-04-16
00849771046363K-Wire and Steinmann Pin DispensersKI71044KI710442025-04-16
00849771046370K-Wire and Steinmann Pin DispensersKI71046KI710462025-04-16
00849771046387K-Wire and Steinmann Pin DispensersKI71047KI710472025-04-16
00849771046394K-Wire and Steinmann Pin DispensersKI71048KI710482025-04-16
00849771013372Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
50849771050617NAK-Wire and Pin CoversC1092025-01-29
10724995225022Electro LubeEL201EL2012024-10-03
00849771048190NAK-Wire and Steinmann Pin DispensersKI710062024-10-03
00849771052562Key Surgical Pipe CleanersPC100CPC100C2024-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776415877MillenniumAvalign Technologies, Inc.HXD2026-02-04
00810123209781Adler Instrument CompanyAdler, Inc.HXD2026-01-28
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00841013124532American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124549American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124556American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124563American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00888480670728Timberline Lateral Fusion SystemHighridge Medical, LLCHXD2025-12-18
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00840277133113Innomed, Inc.INNOMED, INC.HXD2025-12-02
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00840338603944Tornier HRS MaxTORNIER, INC.HXD2025-11-18
03662663137027Polaris 4.75 Deformity SystemHighridge Medical, LLCHXD2025-11-14
00840277133038Innomed, Inc.INNOMED, INC.HXD2025-11-12
00885556768471EVOSSmith & Nephew, Inc.HXD2025-11-12
00885556908846EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911112EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911129EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911136EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911143EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911150EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911167EVOSSmith & Nephew, Inc.HXD2025-11-11