FDA.reportPublic FDA data

ORCA Foam

Primary DI
00860008294357
Brand
ORCA Foam
Company
Orca Products, LLC
Model
Cube
Device description
AbsorbaleGelatin Sponge
Published
2023-09-15
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
KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
LYASplint, Intranasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)Ear, Nose, Throat2
LYASplint, Intranasal SeptalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008294357PrimaryGS10
00860008294364Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008294357008600082943578600082943570860008294357
00860008294364008600082943648600082943640860008294364

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.

Contacts#

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

Regulatory Flags#

DUNS number
117716283
Device count
32
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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
00860008294388ORCA FoamSize 12/72023-09-15
00850056665216ORCA FoamOF-80302025-04-07
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
10850056665305ORCA FoamOrca Products, LLCLYA2026-05-07
16975560670042Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670059Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670066Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670073Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670080Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670097Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670103Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670110Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670257Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670264Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670271Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670288Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670295Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670301Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
00810235030853Prolaryn PlusMERZ NORTH AMERICA, INC.KHJ2026-02-24
04250381820537Expanding sinus tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250381820544Expanding sinus tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676730008MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731104Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731111Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731128Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731135Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676741691Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
00850056665292ORCA Foam PowderOrca Products, LLCKHJ2025-09-30
00850056665223ORCA FoamOrca Products, LLCKHJ2025-04-07
00850056665247ORCA Foam PowderOrca Products, LLCKHJ2025-04-07
00850056665193ORCA Foam Orca Products, LLCKHJ2025-02-25
00850056665193ORCA Foam Orca Products, LLCLYA2025-02-25