FDA.report

Spand-Gel

Primary DI
10274792600183
Brand
Spand-Gel
Company
MEDI-TECH INTERNATIONAL CORPORATION
Model
SPHD01
Catalog number
SPHD01
Device description
Spand-Gel Hydrogel Wound Filler Bellows Bottle 1oz
Published
2019-06-11
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

Related Records

Contact Domains

Product Codes

CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications

CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10274792600183PrimaryGS10
00027479260018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1027479260018310274792600183
00027479260018000274792600180274792600180027479260018

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry area

Sterilization Methods

Method

Contacts

PhoneEmail
414-570-8880Marilyn.Geiger@medi-techintl.com

Regulatory Flags

DUNS number
063865158
Device count
120
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00027479132223MT SpandageMT22X24MT22X242019-06-04
00027479132247MT Spandage MT2X24MT2X242019-06-04
00027479133244MT SpandageMT3X24MT3X242019-06-04
00027479133367MT SpandageMT3X36MT3X362019-06-04
00027479134241MT Spandage MT4X24MT4X242019-06-04
00027479134364MT Spandage MT4X36MT4X362019-06-04
00027479135248MT SpandageMT5X24MT5X242019-06-04
00027479135361MT SpandageMT5X36MT5X362019-06-04
00027479136245MT SpandageMT6X24MT6X242019-06-04
00027479136368MT Spandage MT6X36MT6X362019-06-04
00027479137242MT Spandage MT7X24MT7X242019-06-04
00027479137365MT SpandageMT7X36MT7X362019-06-04
00027479138249MT SpandageMT8X24MT8X242019-06-04

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