FDA.reportPublic FDA data

Cramer Orthogel

Primary DI
10311960619483
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
Rx
false
OTC
true
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007138183
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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

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