FDA.reportPublic FDA data

Spectrum, Inc.

Primary DI
00850301007709
Brand
Spectrum, Inc.
Company
SPECTRUM, INC.
Model
987-03597-000
Catalog number
713322
Device description
"Non-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
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
10850301007706PackageGS110In Commercial Distribution
00850301007709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085030100770610850301007706
00850301007709008503010077098503010077090850301007709

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.

Contacts#

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

Regulatory Flags#

DUNS number
080458964
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978479041074LotfancyAnhui Medsport Medical Products Co., Ltd.FQM2026-06-03
08809302580645New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580676New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580911New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580867New Soosung Elastic Bandagesoosung medicalFQM2025-12-24
08809302587217Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587224Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587231Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587248Soosung Elastic Bandagesoosung medicalFQM2025-12-11
10080196571925MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-10-20
10192253065282CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065299CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065305CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065312CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10080196278237MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196691159MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745593MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745630MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745647MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745722MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745739MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10192253049251DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049268DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049275DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049282DermaceaCardinal Health 200, LLCFQM2025-07-21
10080196990733MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-10
10080196789207MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-02
10080196823536MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-30
10080196692378MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29
10080196823543MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29