FDA.reportPublic FDA data

MINITAPE

Primary DI
20885556727748
Brand
MINITAPE
Company
Smith & Nephew, Inc.
Model
72205129
Catalog number
72205129
Device description
(6) MINITAPE (COBRAID WHITE) 39.5
Published
2019-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132357000SMITH & NEPHEW ULTRATAPESmith & Nephew, Inc.2013-10-30GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885556727748PackageGS16In Commercial Distribution
00885556727744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088555672774820885556727748
00885556727744008855567277448855567277440885556727744

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, multifilamentA multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polyethylene) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
10705031097889ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031102996ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031103085ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031238404ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031461963ETHIBOND EXCELETHICON, LLCGAT2026-07-17
10705031461970ETHIBOND EXCELETHICON, LLCGAT2026-07-17
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHGAT2026-01-18
00888867525924Arthrex®ARTHREX, INC.GAT2025-10-20
00888867525931Arthrex®ARTHREX, INC.GAT2025-10-20
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHGAT2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHGAT2024-04-12
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHGAT2024-02-06
07649990202020Tray_SF Push-In Anchor 2.3Surgical Fusion Technologies GmbHGAT2024-01-10
07649990202181Handpiece Front CoverSurgical Fusion Technologies GmbHGAT2024-01-10
07649990202013Tray_SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202037Sonotrode PI-S 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202044Twist Drill PI-C 1.8Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202051Wrench 5.0Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202150BoneWelder 150-W1Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202167SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-08
00860007711206EasyWhipWinter Innovations Inc.GAT2021-11-18
10884521758803VascufilCovidien LPGAT2020-07-19
10652927144151DemeBONDDemetech CorporationGAT2019-07-16
10652927144168DemeBONDDemetech CorporationGAT2019-07-16
10652927150312DemeBONDDemetech CorporationGAT2019-07-16