FDA.reportPublic FDA data

SMITH & NEPHEW 400

Primary DI
00885554011821
Brand
SMITH & NEPHEW 400
Company
Smith & Nephew, Inc.
Model
7209943
Catalog number
7209943
Device description
S&N 400 INSUFFLATOR KIT ITALIAN
Published
2015-08-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIFINSUFFLATOR, LAPAROSCOPIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K02205200040LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0Northgate Technologies, Inc.2003-01-24HIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885554011821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885554011821008855540118218855540118210885554011821

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic insufflatorA mains electricity (AC-powered) device designed to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space (pneumoperitoneum) in which to perform an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. Other surgical instruments may be introduced into the peritoneal cavity through other laparoscopic ports. This device may also be referred to as a gas distention system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955813360AESCULAPAesculap AGHIF2025-12-02
B3543000011ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000012ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000013ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000014ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000015ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000019ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000010ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
04046955813353AESCULAPAesculap AGHIF2025-05-18
04953170467219HIGH FLOW INSUFFLATION UNITOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-27
04055207007822NARichard Wolf GmbHHIF2024-08-19
04055207008393NARichard Wolf GmbHHIF2024-08-19
04055207058985NARichard Wolf GmbHHIF2024-08-19
05391536920937EVA15PALLIARE LIMITEDHIF2024-07-16
10845854045633AIRSEALConmed CorporationHIF2024-03-27
00886874120699NoneINTUITIVE SURGICAL, INC.HIF2024-03-25
B354OSLPCDG1Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG2Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG3Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG4Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG5Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG51Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG9Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG0Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
00850059707005AccuMedxAccumedx, LLCHIF2024-01-23
00850059707012AccuMedxAccumedx, LLCHIF2024-01-23
10845854045367CONMEDConmed CorporationHIF2023-12-04
09420012433978Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
10850082007186Filter AssemblyARMM INC.HIF2023-06-08
10850082007193Insufflator Filter AssemblyARMM INC.HIF2023-06-08