FDA.reportPublic FDA data

ORCA Foam

Primary DI
00850056665216
Brand
ORCA Foam
Company
Orca Products, LLC
Model
OF-8030
Device description
AbsorbaleGelatin Sponge (80mm x 30mm cylinder)
Published
2025-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056665223PrimaryGS10
00850056665216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056665223008500566652238500566652230850056665223
00850056665216008500566652168500566652160850056665216

GMDN Terms#

Term, Definition table
TermDefinition
Gelatin haemostatic agentA sterile, bioabsorbable device derived from animal gelatin (typically pork skin gelatin) that is intended to be applied to surgical and traumatic wounds to facilitate local haemostasis through its high blood-absorbing capacity; it does not contain an antimicrobial agent. It is typically in the form of a pad/sponge and has no intrinsic haemostatic action but induces haemostasis through its intensely porous structure which enables it to absorb many times its weight in blood; the device is intended to remain in the wound to be absorbed by the body. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
334-803-2370cdsdds@me.com

Regulatory Flags#

DUNS number
117716283
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00850056665223ORCA FoamOF-80302025-04-07
00850056665247ORCA Foam PowderOF-PS-102025-04-07
00850056665292ORCA Foam PowderOF-PS-062025-09-30
10850056665305ORCA FoamOF-4010102026-05-07
10860003109974ORCA FoamSize 12/72022-02-24
10860003109981ORCA FoamSize 502022-02-24
10860003109998ORCA FoamSze 1002022-02-24
10860008294309ORCA FoamSize 50HD2022-02-24
10860008294347ORCA FoamNasal Tampon2023-09-15
00850056665001ORCA Foam Size 1002023-09-15
00850056665025ORCA FoamSize 502023-09-15
00850056665100ORCA Foam PowderOF-012024-12-05
00850056665124ORCA Foam PowderOF-01B2024-12-05
00850056665148ORCA Foam PowderOF-03B2024-12-05
00850056665193ORCA Foam OF-100C2025-02-25
00860003109915ORCA FoamStandard2020-12-15
00860008294333ORCA FoamSize 42023-09-15
00860008294357ORCA FoamCube2023-09-15
00860008294388ORCA FoamSize 12/72023-09-15
10850056665244ORCA Foam PowderOF-PS-102025-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850056665305ORCA FoamOrca Products, LLCKHJ2026-05-07
00810235030853Prolaryn PlusMERZ NORTH AMERICA, INC.KHJ2026-02-24
00850056665292ORCA Foam PowderOrca Products, LLCKHJ2025-09-30
00850056665223ORCA FoamOrca Products, LLCKHJ2025-04-07
00850056665247ORCA Foam PowderOrca Products, LLCKHJ2025-04-07
10850056665244ORCA Foam PowderOrca Products, LLCKHJ2025-04-07
00850056665193ORCA Foam Orca Products, LLCKHJ2025-02-25
00850056665100ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
00850056665124ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
00850056665148ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
00827002602854BiodesignCOOK BIOTECH INCORPORATEDKHJ2024-05-31
10827002602851BiodesignCOOK BIOTECH INCORPORATEDKHJ2024-05-31
10860008294347ORCA FoamOrca Products, LLCKHJ2023-09-15
00850056665001ORCA FoamOrca Products, LLCKHJ2023-09-15
00850056665025ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294333ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294357ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294388ORCA FoamOrca Products, LLCKHJ2023-09-15
10860003109974ORCA FoamOrca Products, LLCKHJ2022-02-24
10860003109981ORCA FoamOrca Products, LLCKHJ2022-02-24
10860008294309ORCA FoamOrca Products, LLCKHJ2022-02-24
08033549791063Epifilm OtologicAnika Therapeutics, Inc.KHJ2022-02-04
04260293133076GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-28
04260293133106GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133144GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133175GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133199GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133083GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133069GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-03-21
00860003109915ORCA FoamOrca Products, LLCKHJ2020-12-15