FDA.reportPublic FDA data

Spectrum, Inc.

Primary DI
10855495007341
Brand
Spectrum, Inc.
Company
SPECTRUM, INC.
Model
982-03922-000
Catalog number
ESS-6920
Device description
Sterile Equipment Drape, ESS Universal Camera Drape, 7" X 96", Latex Free
Published
2017-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPZContainer, frozen donor tissue storage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPZContainer, Frozen Donor Tissue StorageUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934630000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934630000UNIVERSAL VIDEO/LASER ARM DRAPEHydro-Med Products, Inc.1994-10-28KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855495007341PackageGS125In Commercial Distribution
20855495007348PackageGS150In Commercial Distribution
00855495007344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085549500734110855495007341
2085549500734820855495007348
00855495007344008554950073448554950073440855495007344

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. 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
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
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
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20816203023920PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203023937PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024101PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
20816203024125PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
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20816203024354PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2025-06-18
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10816203023688PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
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10816203023701PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
10816203023718PermaLife™ Cell Culture BagORIGEN BIOMEDICAL, INC.LPZ2024-12-06
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10816203023619PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023626PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023633PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
10816203023596PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023609PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023616PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023623PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
20816203023630PermaLifeORIGEN BIOMEDICAL, INC.LPZ2021-11-15
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