FDA.reportPublic FDA data

Karl Schumacher TAPE

Primary DI
00084251710084
Brand
Karl Schumacher TAPE
Company
KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.
Model
RCWT0001
Device description
Resorbable Collagen Dental Wound Dressing
Published
2017-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNDressing, Wound, Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00084251710084PrimaryGS10
00842517100077Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00084251710084000842517100840842517100840084251710084
00842517100077008425171000778425171000770842517100077

GMDN Terms#

Term, Definition table
TermDefinition
General oral wound dressing, animal-derivedA sterile, collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution). It is available [non-prescription] over-the-counter (OTC) for clinical and home use. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043957315
Device count
10
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842517100008Karl SchumacherSYR00012016-09-27
00842517102545Karl Schumacher17.007.012023-11-14
00842517102552Karl Schumacher17.007.022023-11-14
00842517102569Karl Schumacher17.007.032023-11-14
00842517102576Karl Schumacher17.007.042023-11-14
00842517102583Karl Schumacher17.007.052023-11-14
00842517102590Karl Schumacher17.007.05AE2023-11-14
00842517102613Karl Schumacher17.008.012023-11-14
00842517102620Karl Schumacher17.008.022023-11-14
00842517102637Karl Schumacher17.008.032023-11-14
00842517102644Karl Schumacher17.008.042023-11-14
00842517102651Karl Schumacher17.008.052023-11-14
00842517102668Karl Schumacher17.008.05AE2023-11-14
00842517102675Karl Schumacher17.008.062023-11-14
00842517102682Karl Schumacher17.008.06AE2023-11-14
00842517102699Karl Schumacher17.008.082023-11-14
00842517102705Karl Schumacher17.008.08AE2023-11-14
00842517102712Karl Schumacher17.008.092023-11-14
00842517102729Karl Schumacher17.008.09AE2023-11-14
00842517102736Karl Schumacher17.008.102023-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013117504DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00860013117511DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00850016008190BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008206BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008220BaseMEMViscus Biologics LLCKGN2026-09-21
05694310969468MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969482MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969505MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969529MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969543SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969567SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969581SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969604SurgiClose® CompactKERECIS hf.KGN2026-09-18
00841277111262Novera RenewHarps USA, Inc.KGN2026-08-26
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
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00810179632595OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632618OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632632OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632649OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31