FDA.reportPublic FDA data

Karl Schumacher PLUG

Primary DI
00842517100060
Brand
Karl Schumacher PLUG
Company
KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.
Model
RCWP0001
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
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
00842517100060PrimaryGS10
00842517100053Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517100060008425171000608425171000600842517100060
00842517100053008425171000538425171000530842517100053

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
Lot or batch
true
Expiration date on label
true

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
00860012016686MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-06-08
00850084084010CURCOFR TECH, LLCKGN2026-06-02
00850084084027CURCOFR TECH, LLCKGN2026-06-02
00850084084034CURCOFR TECH, LLCKGN2026-06-02
00850084084041CURCOFR TECH, LLCKGN2026-06-02
00850084084058CURCOFR TECH, LLCKGN2026-06-02
00850084084065CURCOFR TECH, LLCKGN2026-06-02
00850084084072CURCOFR TECH, LLCKGN2026-06-02
00850084084089CURCOFR TECH, LLCKGN2026-06-02
00714196003317DermaCol 100 Gel 1oz TubeSion Brands LLCKGN2026-06-01
07610221017737Derma-Gide®Geistlich Pharma AGKGN2026-06-01
00813954028385collateneCOLLAGEN MATRIX, INC.KGN2026-05-05
10840330705858ProCureTwin Med, LLCKGN2026-05-04
10840330705834ProCureTwin Med, LLCKGN2026-04-28
10840330705841ProCureTwin Med, LLCKGN2026-04-28
00812593023119NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023126NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023072NeoSurg Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023089ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023096ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023102ColSyntekBiogennix, LLCKGN2026-04-22
10885632434280HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
10885632434297HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
00324357900012Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00324357900777Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00812593023058Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023065Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023034CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
00812593023041CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
10885632434273HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-03-31