FDA.reportPublic FDA data

Trigen

Primary DI
00885556799345
Brand
Trigen
Company
Smith & Nephew, Inc.
Model
E0017169-5
Catalog number
E0017169-5
Device description
7MM SHARP TIP AWL
Published
2020-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWJAWL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556799345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556799345008855567993458855567993450885556799345

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is 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, typically made of metallic and/or synthetic material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-07-19
18257200051175PROVIEWOrthofix US LLCHWJ2026-07-17
18257200163571PILLAR SA TiOrthofix US LLCHWJ2026-07-17
18257200163588PILLAR SA TiOrthofix US LLCHWJ2026-07-17
18257200163595PILLAR SA TiOrthofix US LLCHWJ2026-07-17
B8034609130ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609140ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609150ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609160ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803030ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803360ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803370ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803380ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803390ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803400ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803410ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
00857915007767IM Nail AwlA.M. SURGICAL, INC.HWJ2026-06-10
00840311245376Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWJ2026-04-30
08800322758137Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWJ2026-04-21
00860015151308EnFix Instrument Kit - CompleteTETROUS, INC.HWJ2026-02-24
00887868287473Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCHWJ2025-11-12
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21
00763000878245n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-20
00840180541050General InstrumentsALPHATEC SPINE, INC.HWJ2025-10-17
00763000885243n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-11
00816342025522AWLPARCUS MEDICAL LLCHWJ2025-09-16