FDA.reportPublic FDA data

Spectrum, Inc.

Primary DI
00850301007365
Brand
Spectrum, Inc.
Company
SPECTRUM, INC.
Model
987-03605-000
Catalog number
714312
Device description
"Sterile Pressure Bandage, Esmarch, 3"" x 12'"
Published
2017-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQMBANDAGE, ELASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850301007372PackageGS120In Commercial Distribution
00850301007365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850301007372008503010073728503010073720850301007372
00850301007365008503010073658503010073650850301007365

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, sterileA sterile strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(214)492-0506hfahrlander@spectrumlabs.com

Regulatory Flags#

DUNS number
080458964
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850301007020Wolf982-03715-000956920WOL2017-01-30
00850301007808Spectrum, Inc.987-03896-0007252002017-07-21
00855495007344Spectrum, Inc.982-03922-000ESS-69202017-07-21
00855495007351Spectrum, Inc.982-03954-001SD-1002017-07-21
00855495007368Spectrum, Inc.982-03955-000GCS-69202017-07-21
00855495007382Spectrum, Inc.982-03963-000956923LUM2017-07-21
00850301007860Spectrum, Inc.985-03651-0007403302017-02-14
00850301007877Spectrum, Inc.985-03652-0007404402017-02-14
00850301007884Spectrum, Inc.985-03666-0007604402017-02-14
00850301007891Spectrum, Inc.985-03667-0007605502017-02-14
00850301007907Spectrum, Inc.985-03668-0007606602017-02-14
00850301007914Spectrum, Inc.985-03691-0007805502017-02-14
00850301007921Spectrum, Inc.985-03692-0007806602017-02-14
00850301007938Spectrum, Inc.985-03526-0007020442017-02-14
00850301007945Spectrum, Inc.985-03527-0007030332017-02-14
00850301007952Spectrum, Inc.985-03528-0007030442017-02-14
00850301007969Spectrum, Inc.985-03529-0007040332017-02-14
00850301007976Richard WOLF985-03530-0007040442017-02-14
00850301007983Spectrum, Inc.985-03531-0007040552017-02-14
00850301007990Spectrum, Inc.985-03532-0007040662017-02-14

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Primary DI, Brand, Company table
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