FDA.reportPublic FDA data

SkinTemp II

Primary DI
00850048866157
Brand
SkinTemp II
Company
Human Biosciences Inc.
Model
ST1002
Device description
SkinTemp sterile collagen wound dressing, 3x4 sheet
Published
2023-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

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
00850048866157PackageGS15In Commercial Distribution
00850048866089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048866157008500488661578500488661570850048866157
00850048866089008500488660898500488660890850048866089

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
301-740-1893info@humanbiosciences.com

Regulatory Flags#

DUNS number
014511541
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048866928CelluhealCF20022025-11-17
00850048866966Collecule LpHCSP10012025-11-17
00850048866942SkinTemp IIST105102025-06-16
00850048866034CelluhealCS10222023-09-28
00850048866058MedifilMF20022023-06-19
00850048866089SkinTemp IIST10022023-06-19
00850048866096SkinTemp IIST10222023-06-19
00850048866102SkinTemp IIST10772023-06-19
00850048866119SkinTemp IIST10032023-06-19
00850048866126MedifilMF20012023-06-19
00850048866041CelluhealCF20012023-09-28
00850048866133CollatekCG10012023-06-19
00850048866959CelluhealCS105102025-06-16
00850048866300CelluhealCS10222023-09-28
00850048866195MedifilMF20022023-06-19
00850048866140SkinTemp IIST10222023-06-19
00850048866164SkinTemp IIST10772023-06-19
00850048866171SkinTemp IIST10032023-06-19
00850048866188MedifilMF20012023-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632472OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632649OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632663OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632687OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632694OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632717OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632724OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632731OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00850084084010CURCOFR TECH, LLCKGN2026-06-02
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