FDA.reportPublic FDA data

Spand-Gel

Primary DI
30274792510615
Brand
Spand-Gel
Company
MEDI-TECH INTERNATIONAL CORPORATION
Model
SPHSA3
Catalog number
SPHSA3
Device description
Spand-Gel Hydrogel Dressing Sheet - Size 3 IN x 8 IN - Sterile
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
true
Single use
true

Contact Domains#

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
30274792510615PrimaryGS10
00027479251061Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3027479251061530274792510615
00027479251061000274792510610274792510610027479251061

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, sterileA 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 and gases. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry area

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
414-570-8880Marilyn.Geiger@medi-techintl.com

Regulatory Flags#

DUNS number
063865158
Device count
30
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00027479153259SpandaNetteMTSNP15325MTSNP153252019-10-29
00027479132254SpandaNette MTSN13225MTSN132252019-10-29
00027479134258SpandaNetteMTSN13425MTSN134252019-10-29
00027479135255SpandaNette MTSN13525MTSN135252019-10-29
00027479131059SpandaNetteMTSN131025MTSN1310252019-10-29
00027479131257SpandaNetteMTSN31225MTSN312252019-10-29
00027479131455SpandaNetteMTSN131425MTSN1314252019-10-29
00027479133251SpandaNette MTSN13325MTSN133252019-10-29
00027479136252SpandaNette MTSN13625MTSN136252019-10-29
00027479138256SpandaNetteMTSN13825MTSN138252019-10-29
00027479152252SpandaNetteMTSNP15225MTSNP152252019-10-29
00027479142505SpandaNette MTSNB14250MTSNB142502019-09-11
00027479143502SpandaNette MTSNB14350MTSNB143502019-09-11
00027479144509SpandaNette MTSNB14450MTSNB144502019-09-11
00027479145506SpandaNette MTSNB14550MTSNB145502019-09-11
00027479146503SpandaNetteMTSNB14650MTSNB146502019-09-11
00027479148507SpandaNetteMTSNB14850MTSNB148502019-09-11
00027479151057SpandaNetteMTSNP151025MTSNP1510252019-09-11
00027479151255SpandaNetteMTSNP151225MTSNP1512252019-09-11
00027479151453SpandaNette MTSNP151425MTSNP1514252019-09-11

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00810040134692SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
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00361554005638GentellGentell, LLCNAE2025-02-14