FDA.reportPublic FDA data

DERMAGRAN®-B

Primary DI
30381780491815
Brand
DERMAGRAN®-B
Company
Derma Sciences Canada Inc
Model
SPD-03
Catalog number
DERMA-SPD03
Device description
Hydrophilic Wound Dressing with Zinc Plus Vitamins A and B6 For Skin Ulcers (Diabetic, Venous Stasis), and Stage I-IV Pressure Sores
Published
2018-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGPDRESSING, WOUND AND BURN, OCCLUSIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGPDressing, Wound And Burn, OcclusiveUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954739000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954739000DERMAGRAN HYDROPHILIC OINTMENTDerma Sciences, Inc.1995-11-02FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780491815PackageGS112In Commercial Distribution
10381780491811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178049181530381780491815
1038178049181110381780491811

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
200564891
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00809958093108Ducare®9409SDUP9409S2019-03-06
00809958013502Dupress®11903DUP119032018-11-13
00809958013601Dupress®11904DUP119042018-11-13
00809958013809Dupress®11907DUP119072018-10-23
00809958013908Dupress®11908DUP119082018-10-23
00809958080115DuCare®82208DUP822082018-10-23
00809958080214DuCare®82212DUP822122018-10-23
00809958080412DuCare®82312DUP823122018-10-23
00809958080511DuCare®82408DUP824082018-10-23
00809958080610DuCare®82412DUP824122018-10-23
00809958080719DuCare®82812DUP828122018-10-23
00809958080818DuCare®82815DUP828152018-10-23
00809958082010DuCare®82910DUP829102018-10-23
00809958084113DuCare®82410DUP824102018-11-20
00809958087411PrimaPad®83338DUP833382018-10-23
00809958087510PrimaPad®83334DUP833342018-10-23
00809958087619PrimaPad®83323DUP833232018-10-23
00809958090510DuCare®90208DUP902082018-11-13
00809958090619DuCare®90212DUP902122018-11-13
00809958090718DuCare®90308DUP903082018-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30884389803114MEDLINEMEDLINE INDUSTRIES, INC.MGP2024-08-06
00810050460033Silon-TSR 11x12Bio Med Sciences, Inc.MGP2023-12-31
00810050460101Dual-Dress 50 11x12Bio Med Sciences, Inc.MGP2023-12-31
00810050460118Dual-Dress 50 11x24Bio Med Sciences, Inc.MGP2023-12-31
10810050460030Silon-TSR 11x12Bio Med Sciences, Inc.MGP2023-12-31
10810050460108Dual-Dress 50 11x12Bio Med Sciences, Inc.MGP2023-12-31
10810050460115Dual-Dress 50 11x24Bio Med Sciences, Inc.MGP2023-12-31
00810050460019Silon-TSR 5x5Bio Med Sciences, Inc.MGP2023-08-04
00810050460026Silon-TSR 5x10Bio Med Sciences, Inc.MGP2023-08-04
00810050460040Silon-TSR Face Mask DesignBio Med Sciences, Inc.MGP2023-08-04
00810050460057Silon-TSR Face Mask KitBio Med Sciences, Inc.MGP2023-08-04
10810050460016Silon-TSR 5x5Bio Med Sciences, Inc.MGP2023-08-04
10810050460023Silon-TSR 5x10Bio Med Sciences, Inc.MGP2023-08-04
10810050460047Silon-TSR Face Mask DesignBio Med Sciences, Inc.MGP2023-08-04
10810050460054Silon-TSR Face Mask KitBio Med Sciences, Inc.MGP2023-08-04
00050428287071CVS Health™WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDMGP2022-09-24
M7528900120Stradis Medical, LLC.STRADIS MEDICAL, LLCMGP2022-06-01
M7528900030STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528900031STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528910030STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528204040STRADIS STRADIS MEDICAL, LLCMGP2022-05-16
M7528900070STRADIS HEALTHCARESTRADIS MEDICAL, LLCMGP2022-03-31
00856525007365PFAB SMALLSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007372PFAB MediumSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007389PFAB Medium CrescentSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007396PFAB LargeSUN SCIENTIFIC, INC.MGP2021-04-30
05000223449889"ACTICOAT 4""X48"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-09-18
00040565121536ACTICOAT 4"X48"SMITH & NEPHEW MEDICAL LIMITEDMGP2020-09-18
00040565122045"ACTICOAT 3 5"" X 5"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-07-16
05000223449766"ACTICOAT 4"" X 4"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-07-16