FDA.reportPublic FDA data

Collecule LpH

Primary DI
00850048866966
Brand
Collecule LpH
Company
Human Biosciences Inc.
Model
CSP1001
Device description
Collecule LpH Surgical Collagen powder, 1gram
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)
KOZBeads, Hydrophilic, For Wound Exudate Absorption

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU
KOZBeads, Hydrophilic, For Wound Exudate AbsorptionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048866966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048866966008500488669668500488669660850048866966

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3017401893info@humanbiosciences.com

Regulatory Flags#

DUNS number
014511541
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048866928CelluhealCF20022025-11-17
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
00850048866157SkinTemp IIST10022023-06-19
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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00810179632663OASISCOOK 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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