FDA.reportPublic FDA data

Cramer Orthogel

Primary DI
00311960619486
Brand
Cramer Orthogel
Company
CRAMER PRODUCTS, INC.
Model
061925
Device description
"Cramer Orthogel Kit - One 12"" x 12"" sheet of 1/8"", 1/4"" and 3/8"" thick sheets"
Published
2019-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10311960619483PackageGS19In Commercial Distribution
00311960619486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1031196061948310311960619483
00311960619486003119606194863119606194860311960619486

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-sterileA non-sterile wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids/gases. Some types are intended to reduce hypertrophic/keloid scars by providing a barrier impermeable to liquids/gases to maintain a moist environment. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of reach of children.

Regulatory Flags#

DUNS number
007138183
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20311960752019Cramer All Sports Athletic Tape Pink Zebra 7627202018-09-19
00311960001397Cramer Athletic Tape 7628202018-10-02
00311960001403Cramer Athletic Tape 2pk Blister, White7628252018-10-02
00311960002226Cramer Super Stretch Non-tear Tape2842302018-09-27
00311960002233Cramer Super Stretch Non-tear Tape2843302018-09-27
00311960548588Cramer 950 Athletic Trainer's Tape2820502018-09-25
00311960686037Cramer 950 Athletic Trainer's Tape2821012018-09-25
00311960686044Cramer 950 Athletic Trainer's Tape2821022018-09-25
00311960686228Cramer Athletic Tape 6pk, White7628262018-10-02
00311960686235Cramer 750 Athletic 6 Pack Tape - Black7628212018-10-02
00311960708302Cramer Blister Foam0309072018-10-01
00311960708319Cramer Blister Foam0309082018-10-01
00311960751636Cramer All Sports Athletic Tape 7627002018-09-19
00311960751643Cramer All Sports Athletic Tape 7627012018-09-19
00311960751650Cramer All Sports Athletic Tape 7627022018-09-21
00311960751667Cramer All Sports Athletic Tape 7627032018-09-21
00311960751674Cramer All Sports AthleticTape 7627042018-09-21
00311960751681Cramer All Sports Athletic Tape 7627052018-09-21
00311960751698Cramer All Sports Athletic Tape 7627062018-09-21
00311960751704Cramer All Sports Athletic Tape Retail blister, white7627072018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970206829191PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206829207PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206820808kegel Hydrogel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-22
01714196112452DermaRite Medical Wound Gel- Amorphous HydrogelSion Brands LLCNAE2026-06-01
00850060751738SkinPenBellus Medical, LLCNAE2026-05-20
00860015727336KegelStar Port IncNAE2026-04-27
10840330704936ProCureTwin Med, LLCNAE2026-04-22
10840330704943ProCureTwin Med, LLCNAE2026-04-22
10840330705803ProCureTwin Med, LLCNAE2026-04-22
10840330705810ProCureTwin Med, LLCNAE2026-04-22
10840330706350ProCureTwin Med, LLCNAE2026-04-22
00324357010155Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00743537000456First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000470MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
10197344017508MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-10-23
00858071004478Natural Shield Wound Dressing, 1oz brush onKericure Inc.NAE2025-10-06
00858071004553Natural Shield Wound Dressing, 1oz sprayKericure Inc.NAE2025-10-06
20192253040156KendallCardinal Health 200, LLCNAE2025-09-26
00197998326882Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
00197998326967Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
15056860000034Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000041Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000058Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
10197344110162MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-08-04
M689HHWSK02050Wound Seal KitSafeguard US Operating, LLCNAE2025-06-24
00810040134692SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00810040134708SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00361554005614GentellGentell, LLCNAE2025-02-14