FDA.reportPublic FDA data

BandGrip® Micro-Anchor® Closure

Primary DI
10850010207152
Brand
BandGrip® Micro-Anchor® Closure
Company
BANDGRIP INC.
Model
BG 1005
Catalog number
BG 1005
Device description
5 cm x 7.5 strips; 2 strips/pouch
Published
2020-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKYSYSTEM, SKIN CLOSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKYSystem, Skin ClosureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850010207152PackageGS120In Commercial Distribution
00850010207155PrimaryGS10
00850010207148Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001020715210850010207152
00850010207155008500102071558500102071550850010207155
00850010207148008500102071488500102071480850010207148

GMDN Terms#

Term, Definition table
TermDefinition
Skin-closure adhesive stripA small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length5Centimeter
Length7.6Centimeter
Width5Centimeter
Width7.5Centimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(844)968-6322customerservice@bandgrip.com

Regulatory Flags#

DUNS number
080545512
Device count
36
DM exempt
true
Premarket exempt
true
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850010207131BandGrip® Micro-Anchor® Skin ClosureBG1003-FBG1003-F2020-03-25
00850010207155BandGrip® Micro-Anchor® Skin ClosureBG 1005BG 10052020-07-27
00850010207179BandGrip® Micro-Anchor® Skin ClosureBG 1005-FBG1005-F2020-07-27
10850010207138BandGrip® Micro-Anchor® Skin ClosureBG1003-FBG1003-F2020-03-25
00850010207094BandGrip® Micro-Anchor® Skin ClosureBG1000BG10002021-03-01
00850010207193BandGrip® Micro-Anchor® Skin ClosureBG1000-FBG1000F2021-03-01
10850010207091BandGrip® Micro-Anchor® Skin ClosureBG1000BG10002021-03-01
10850010207190BandGrip® Micro-Anchor® Skin ClosureBG1000-FBG1000F2021-03-01
00850010207070BandGrip® Micro-Anchor® Skin ClosureBG1001BG10012020-03-24
00850010207087BandGrip® Micro-Anchor® Skin ClosureBG1001-FBG1001-F2020-03-24
00850010207100BandGrip® Micro-Anchor® Skin ClosureBG1002BG10022020-03-24
00850010207117BandGrip® Micro-Anchor® Skin ClosureBG1002-FBG1002-F2020-03-24
00850010207124BandGrip® Micro-Anchor® Skin ClosureBG1003BG10032020-03-24
10850010207176BandGrip® Micro-Anchor® ClosureBG 1005-FBG1005-F2020-07-27
30850010207071BandGrip® Micro-Anchor® ClosureBG1001BG10012020-03-24
10850010207084BandGrip® Micro-Anchor® ClosureBG1001-FBG1001-F2020-03-24
10850010207107BandGrip® Micro-Anchor® ClosureBG1002BG10022020-03-24
10850010207114BandGrip® Micro-Anchor® ClosureBG1002-FBG1002-F2020-03-24
10850010207121BandGrip® Micro-Anchor® ClosureBG1003BG10032020-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007834257SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
10860007834254SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
06972864363024sknjxNingbo Chinmed Technology Co., Ltd.MKY2025-11-20
00844735006728DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
00844735006735DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
07540161750015AbCloInventorr MD IncMKY2023-12-04
00840118605175ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611435ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611459ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611473ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611497ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611510ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611534ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611558ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613644ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118605182ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611442ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611466ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611480ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611503ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611527ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611541ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611565ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613651ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
08800125000020DIALFIX 11DFIXMKY2023-01-28
08800125000037DIALFIX 15DFIXMKY2023-01-28
08800125000044DIALFIX 18DFIXMKY2023-01-28
08800125000051DIALFIX 21DFIXMKY2023-01-28
08800125000068DIALFIX 24DFIXMKY2023-01-28
08800125000075DIALFIX PLUS 3DFIXMKY2023-01-28