FDA.reportPublic FDA data

ACM Surgical Collagen

Primary DI
00366977333337
Brand
ACM Surgical Collagen
Company
Mpm Medical, LLC
Model
1
Catalog number
MP00333
Device description
ACM Surgical Collagen Matrix 3x3 (1/bx; 10/cs)
Published
2022-12-07
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
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
10366977333334PackageGS11In Commercial Distribution
20366977333331PackageGS110In Commercial Distribution
00366977333337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1036697733333410366977333334
2036697733333120366977333331
00366977333337003669773333373669773333370366977333337

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
081241522
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
true
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
00366977010252CoMatryx Surgical Bovine Type 1 Collagen 2.5mL1COM102022-12-07
00366977020053CoMatryx Surgical Bovine Type 1 Collagen2COM202022-12-07
00366977020503MetaMatrix Surgical Bovine Type 1 Collagen2META202022-12-07
00366977102506MetaMatrix Surgical Bovine Type 1 Collagen2META102022-12-07
00366977310222MPM Triple Helix Collagen Drsg 2X21MP003102022-12-07
00366977311014Triple Helix Collagen Powder6MP003112022-12-07
00366977312127"MPM Triple Helix Collagen Wound Drsg 12"" Rope"1MP003122022-12-07
00366977314442MPM Triple Helix Collagen Dressing 4x41MP003142022-12-07
00366977315012MPM Triple Helix Collagen Powder2mp003152022-12-07
00366977329828ACM Surgical Collagen1MP003292022-12-07
00366977334457ACM Surgical Extra Advanced Collagen2MP003342022-12-07
00366977337779ACM Surgical Extra Collagen2MP003372022-12-07
00366977345019ACM Surgical Collagen2MP003452022-12-07
00366977377775MPM Medical2MP003772022-12-07
00366977140454MPM SilverMed Antimicrobial Hydrogel2ABSM14042022-12-07
00366977141031MPM SilverMed3ABSM14102022-12-07
00366977141581MPM SilverMed3ABSM14152022-12-07
00366977206334MPM CoolMagic3MP002062022-12-07
00366977208680MPM Cool Magic6MP002082022-12-07
00366977140157MPM SilverMed Antimicrobial Hydrogel3ABSM14062022-12-07

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Primary DI, Brand, Company table
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