FDA.report

Busse Hospital Disposables

Primary DI
00849233012202
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
686
Catalog number
686
Device description
Blue Laminated Drape 22"x25"
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KKXDrape, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10849233013411PackageGS180In Commercial Distribution
00849233012202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301341110849233013411
00849233012202008492330122028492330122020849233012202

GMDN Terms

TermDefinition
Patient surgical drape, single-use, sterileA sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1 (631) 435-4711mail@busseinc.com

Regulatory Flags

DUNS number
002418234
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

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10849233013572Busse Hospital Disposables8917R12025-06-23
10849233013497Busse Hospital Disposables28832025-05-06
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10849233012827Busse Hospital Disposables28542025-03-12
10849233012810Busse Hospital DisposablesB17162025-03-11
10849233012780Busse Hospital Disposables28972025-03-04

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