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
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556925195REAL INTELLIGENCEROB10024FROB10024F2026-07-30
00885556925201REAL INTELLIGENCEROB10025FROB10025F2026-07-30
00885556925218REAL INTELLIGENCEROB10027FROB10027F2026-07-30
00885556925225REAL INTELLIGENCEROB10003FROB10003F2026-07-30
00885556925232REAL INTELLIGENCEROB10013FROB10013F2026-07-30
00885556925249REAL INTELLIGENCEROB10015FROB10015F2026-07-30
00885556832448Salto Talaris Total Ankle ProsthesisMJU048TMJU048T2023-02-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093258ELMED INCORPORATEDELMED INCORPORATEDNBH2026-07-28
00810143908534SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909449SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909456SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909463SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909470SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909487SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909494SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909500SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909531SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909555SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909562SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909579SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909623SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909630SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909647SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909654SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909661SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909678SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909685SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909791SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934334SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934341SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934358SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934365SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934372SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934389SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934396SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934402SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934419SURGIPROSSurgipros, LLCNBH2026-07-28