FDA.reportPublic FDA data

BandGrip® Micro-Anchor® Skin Closure

Primary DI
00850010207070
Brand
BandGrip® Micro-Anchor® Skin Closure
Company
BANDGRIP INC.
Model
BG1001
Catalog number
BG1001
Device description
9 cm x 4 cm; w/ 2 Strips
Published
2020-03-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZQCLIP, REMOVABLE (SKIN)
GDTSTAPLE, REMOVABLE (SKIN)
KGXTape and bandage, adhesive
MKYSYSTEM, SKIN CLOSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZQClip, Removable (Skin)General, Plastic Surgery1
GDTStaple, Removable (Skin)General, Plastic Surgery1
KGXTape And Bandage, AdhesiveGeneral Hospital1
MKYSystem, Skin ClosureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850010207071PackageGS120Not in Commercial Distribution
00850010207070PrimaryGS10
00850010207001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085001020707130850010207071
00850010207070008500102070708500102070700850010207070
00850010207001008500102070018500102070010850010207001

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
Length9Centimeter
Width4Centimeter

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
Lot or batch
true
Expiration date on label
true
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
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
10850010207152BandGrip® Micro-Anchor® ClosureBG 1005BG 10052020-07-27
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

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Primary DI, Brand, Company table
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