FDA.report

AESCULAP

Primary DI
04046964100673
Brand
AESCULAP
Company
Aesculap AG
Model
PO830SU
Catalog number
PO830SU
Device description
METZENBAUM ADTEC SINGLE USE Dissecting Scissors, complete instrument, monopolar, curved to left, working length: 11 1/2", (290 mm),diam. 3,50 mm, rotatable, insulated, double action, sterile, disposable, package of 5 pieces
Published
2016-10-10
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
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964100673PrimaryGS10
04046964100666Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964100673040469641006734046964100673
04046964100666040469641006664046964100666

GMDN Terms

TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
5
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17
04038653038282AESCULAPDP540RDP540R2020-06-17
04038653038299AESCULAPDP541RDP541R2020-06-17
04038653038305AESCULAPDP542RDP542R2020-06-17
04038653177011AESCULAPOG961ROG961R2016-09-23
04038653251407AESCULAPOG960ROG960R2016-09-23
04038653044207MIASPAS MINI-ALIFFF569RFF569R2020-06-17
04038653044214MIASPAS MINI-ALIFFF571RFF571R2020-06-17
04038653044252MIASPAS MINI-ALIFFF578RFF578R2020-06-17
04038653044283MIASPAS MINI-ALIFFF586RFF586R2020-06-17
04038653117307AESCULAPNH196NH1962017-01-27
04038653117352AESCULAPNH206NH2062017-01-27
04038653118540AESCULAPNK088NK0882015-11-11
04038653118557AESCULAPNK089NK0892015-09-24
04038653118564AESCULAPNK090NK0902015-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776417895MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418298MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418304MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418311MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00817428021551ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
10817428021558ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
00198506089527ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-13
10649111501326Sklar InstrumentsSKLAR CORPORATIONGCJ2026-03-12
00190776417840MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417857MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417864MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417888MillenniumAvalign Technologies, Inc.GCJ2026-03-11
B382SD4387110Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD481753PTSTR0Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD4817570Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
B382SD4817590Surgical DirectSurgical Direct, Inc.GCJ2026-03-09
00198506088964ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089060ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089077ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
00198506089084ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-03
B382SD56534910Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
B382SD56740240Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
B382SD76500310Surgical DirectSurgical Direct, Inc.GCJ2026-03-02
04251303824985BLUEENDOTROKAMED GmbHGCJ2026-02-27
00198506088704ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-25
00198506088711ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-25
00198506088216ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088483ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23
00198506088490ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-02-23