FDA.report

Kirwan

Primary DI
00841019107850
Brand
Kirwan
Company
KIRWAN SURGICAL PRODUCTS LLC
Model
50-1004
Device description
Bankart Shoulder Repair Instrument 7 1/2" (19cm) Curved Awl
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
00841019107850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841019107850008410191078508410191078500841019107850

GMDN Terms

TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Length7.5Inch

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

Other Devices From This Company

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00841019123799Kirwan12-1633AUS2026-02-20
00841019123706Kirwan10-3442AUS2026-02-11
00841019123676Kirwan20-1620AUS2026-02-07
00841019123683Kirwan10-5603AUS2026-01-31
00841019123690Kirwan10-5603AUS2026-01-31
00841019123669Kirwan12-1432AUS2026-01-29
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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