FDA.reportPublic FDA data

NA

Primary DI
07613327170207
Brand
NA
Company
Berchtold Holding GmbH
Model
OZ 1001101
Catalog number
OZ 1001101
Device description
Anesthesia screen with radial setting. Keep Dry.
Published
2021-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CCXSUPPORT, PATIENT POSITION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327170207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327170207076133271702077613327170207

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia screenA frame-like device designed to provide a barrier between the sterile surgical site (i.e., where the surgeon operates) and the non-sterile area where the anaesthesiologists and other staff work during a procedure. It is typically fixed to the side rail of the operating table, and surgical drapes are hung over it or from it to create the hygienic partition. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153824
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327169980OperonOT 7701075OT 77010752019-08-27
07613327170047OperonOT 8204675OT 82046752019-08-27
07613327170085OperonOT 8302175OT 83021752019-08-21
07613327170146OperonOT 8602175OT 86021752019-08-21
07613327170269OperonOT 8601175OT 86011752019-08-21
07613327296167ChromophareCH00000001CH000000012016-09-23
07613327459524NAOZ 1509900OZ 15099002021-05-25
07613327170030OperonOT 7606575OT 76065752019-08-27
07613327296228ChromophareCM00000001CM000000012016-09-23
07613327170009OperonOT 8204575OT 82045752019-08-27
07613327296143Chromophare F300CG2903175CG 29031752016-09-23
07613327296259ChromophareCW00000001CW000000012016-09-23
07613327616545SircaCE3863075CE 38630752023-07-14
07613327616569SircaCF3893075CF 38930752023-07-14
07613327616620SircaCG3913275CG 39132752023-07-14
07613327616644SircaCG3913175CG 39131752023-07-14
07613327622706SircaCE3853075CE 38530752023-03-02
07613327169874OperonOT 1702075OT 17020752019-08-27
07613327169935OperonOT 1702175OT 17021752019-08-27
07613327169898OperonOT 1701075OT 17010752019-08-27

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00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
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