FDA.report

PEAK MEDICAL

Primary DI
G4533312070
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
33-1207
Device description
BAYLOR SUMP TUBE LARGE, TIP 6.4MM OD ANGLED 90° 6.9CM X 6.2CM DEEP. REMOVABLE SUMP TIP
Published
2024-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G4533312070PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
078393632
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
G453230117BCL0PEAK MEDICAL23-0117BC-L2026-03-23
G453230117BCR0PEAK MEDICAL23-0117BC-R2026-03-23
G453CFK1000PEAK MEDICALCFK-1002026-03-23
G453FA06160PEAK MEDICALFA0-6162026-03-19
G453AR130PEAK MEDICALAR-132026-03-11
G453PM11812CH1PEAK MEDICALPM11-812-CH2026-03-10
G453PM11815CH0PEAK MEDICALPM11-815-CH2026-03-10
G453335200112L0PEAK MEDICAL3352001-12L2026-01-05
G4533352003290PEAK MEDICAL3352003-292026-01-05
G4533353003310PEAK MEDICAL3353003-312026-01-05
G453333553810PEAK MEDICAL3335-53812026-01-02
G453CD351170PEAK MEDICALCD3-51172025-12-07
G453CD433180PEAK MEDICALCD4-33182025-12-07
G453CD455160PEAK MEDICALCD4-55162025-12-07
G453CD467140PEAK MEDICALCD4-67142025-12-07
G453335243001H0PEAK MEDICAL3352430-01H2025-08-20
G453335243002H0PEAK MEDICAL3352430-02H2025-08-20
G453335243003H0PEAK MEDICAL3352430-03H2025-08-20
G4533352105310PEAK MEDICAL335210-5312025-08-13
G453PM57246210PEAK MEDICALPM57246-212025-07-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G453CFK1000PEAK MEDICALPeak Medical Distribution Inc.GEA2026-03-23
G453AR130PEAK MEDICALPeak Medical Distribution Inc.GEA2026-03-11
00810130456109Medco ManufacturingMedco Manufacturing LLCGEA2026-02-27
00850080243145T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
00850080243152T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
00850080243169T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
20860002896964TalarusCannuflow, Inc.GEA2026-01-28
04058749082937NAFehling Instruments GmbH & Co. KGGEA2026-01-28
00840329836795N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-16
00840329837013N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-16
07630542741012CannulaMedacta International SAGEA2026-01-16
07630542741029CannulaMedacta International SAGEA2026-01-16
07630542741036CannulaMedacta International SAGEA2026-01-16
07630542746499CannulaMedacta International SAGEA2026-01-16
07630542746505CannulaMedacta International SAGEA2026-01-16
07630542746512CannulaMedacta International SAGEA2026-01-16
00840329836375N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836382N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836399N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836405N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836412N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836429N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836443N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836450N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836467N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836474N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836481N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836498N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836504N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836542N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15