FDA.reportPublic FDA data

FIRSTPASS

Primary DI
00817470000184
Brand
FIRSTPASS
Company
Smith & Nephew, Inc.
Model
22-4036
Catalog number
22-4036
Device description
FIRSTPASS NEEDLE AND SUTURE CAPTURE, 5 PER BOX
Published
2017-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBHACCESSORIES,ARTHROSCOPIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817470000188PackageGS15In Commercial Distribution
00817470000184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081747000018820817470000188
00817470000184008174700001848174700001840817470000184

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, single-useA cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010482280CLEAR-TRAC721012172101212015-10-22
03596010532619NA721071972107192015-08-30
03596010505132SCULPTOR721069772106972015-08-30
03596010505149SCULPTOR721069672106962015-08-30
03596010505170SCULPTOR721069572106952015-08-30
03596010505194SCULPTOR721070072107002015-08-30
00885554016703560P72202351722023512015-08-29
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867576070Arthrex®ARTHREX, INC.NBH2026-10-20
00888867576087Arthrex®ARTHREX, INC.NBH2026-10-20
00888867568280Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568297Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568303Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568310Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568457Arthrex®ARTHREX, INC.NBH2026-10-16
B382SD4830070Surgical DirectSurgical Direct, Inc.NBH2026-10-15
B382SD4840320Surgical DirectSurgical Direct, Inc.NBH2026-10-15
B382SD18146S90Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316490Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316690Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316890Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD4810320Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD482014PH0Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD482036PH0Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD4843590Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD488200810Surgical DirectSurgical Direct, Inc.NBH2026-10-13
00888867620964Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620971Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620988Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620995Arthrex®ARTHREX, INC.NBH2026-10-12
00190776434021MillenniumAvalign Technologies, Inc.NBH2026-10-09
00190776434106MillenniumAvalign Technologies, Inc.NBH2026-10-09
00190776433680MillenniumAvalign Technologies, Inc.NBH2026-10-07
00190776433123MillenniumAvalign Technologies, Inc.NBH2026-10-01
04055207071786NARichard Wolf GmbHNBH2026-10-01
04055207071830NARichard Wolf GmbHNBH2026-10-01
00190776431495MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776432119MillenniumAvalign Technologies, Inc.NBH2026-09-22