FDA.report

Kirwan

Primary DI
00841019107928
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
50-1012
Device description
Bankart Shoulder Repair Instrument 11" (28cm) Muscle Retractor
Published
2016-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HAOInstrument, Surgical, Non-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841019107928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841019107928008410191079288410191079280841019107928

GMDN Terms

TermDefinition
Orthopaedic retractorA hand-held manual surgical instrument designed to separate and/or draw back tissues to permit access to skeletal structures for examination or intervention. It is made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Length11Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
781-834-9500kprario@ksp.com

Regulatory Flags

DUNS number
046355210
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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00841019123683Kirwan10-5603AUS2026-01-31
00841019123690Kirwan10-5603AUS2026-01-31
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00841019123614Kirwan10-1403AUS2025-12-24
00841019123621Kirwan20-1413EAUS2025-11-14
00841019123003Kirwan22-1632PL2025-09-27
00841019123584Kirwan12-1633AUS2025-09-11
00841019123607Kirwan14-7000S2025-09-04
00841019123454Kirwan21-1409AUS2025-09-03
00841019123461Kirwan21-1413AUS2025-09-03
00841019123478Kirwan21-1417AUS2025-09-03
00841019123485Kirwan21-1421AUS2025-09-03
00841019123492Kirwan24-1430AUS2025-09-03
00841019123515Kirwan10-5404NSS2025-09-03
00841019123539Kirwan15-5303S2025-09-03
00841019123522Kirwan15-5303S2025-08-29
00841019123416Kirwan12-1637AUS2025-08-02

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