FDA.reportPublic FDA data

Spectrum, Inc.

Primary DI
10850301007751
Brand
Spectrum, Inc.
Company
SPECTRUM, INC.
Model
982-03612-000
Catalog number
721241
Device description
Sterile Heel/Elbow Flotation Cushion, Regular Size
Published
2017-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KICCUSHION, FLOTATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850301007751PackageGS12In Commercial Distribution
20850301007758PackageGS124In Commercial Distribution
00850301007754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085030100775110850301007751
2085030100775820850301007758
00850301007754008503010077548503010077540850301007754

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made cushionA soft pillow or pad that is specially designed for an individual to provide support, comfort, or assist the user to fulfill a functional requirement.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080458964
Device count
1
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
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
10197344014347MEDLINEMEDLINE INDUSTRIES, INC.KIC2026-05-08
00613732114824ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114831ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114848ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114855ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114862ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114879ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114886ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114893ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114909ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114916ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114923ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114930ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114947ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114954ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114961ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114978ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114985ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114992ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115005ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115012ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115029ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115036ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115043ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115050ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115067ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115074ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115081ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115098ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115104ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09