FDA.reportPublic FDA data

ORCA Foam

Primary DI
00860008294371
Brand
ORCA Foam
Company
Orca Products, LLC
Model
Size 12/7
Device description
AbsorbaleGelatin Sponge
Published
2023-09-15
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
LYASplint, Intranasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060878000GELITA-SPON ABSORBABLE GELATIN SPONGE, USPCuramedical, BV2006-04-13KHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008294388PrimaryGS10
00860008294371Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008294388008600082943888600082943880860008294388
00860008294371008600082943718600082943710860008294371

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
10
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
00850056665216ORCA FoamOF-80302025-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06975560670045Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670052Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670069Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670076Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670083Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670090Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670100Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
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