NA

Primary DI
H679352260S0
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
352.260S
Catalog number
352260S
Device description
LOCKING CLIP-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
Published
2016-06-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042899000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042899000SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONSSynthes (Usa)2005-03-16HTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982194619PrimaryGS10
H679352260S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698219461910886982194619

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
Device count
1
DM exempt
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982249210NA60.550.040605500402017-02-20
10886982239884NA530.4125304122016-12-31
10886982192172NA329.7223297222017-02-20
10886982192295LC-DCP329.9183299182017-02-20
10886982201461NA398.56398562017-02-20
10886982201478NA398.58398582017-02-20
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840096408690Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408706Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408713Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408720Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408737Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408744Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408751Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408768Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408775Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408782Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408799Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408805Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408812Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408829Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408836Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408843Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408850Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408867Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408874Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408881Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408898Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408904Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408911Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408928Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408935Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408942Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408959Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408966Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408973Viant Medical, LLCVIANT MEDICALHTO2020-09-03
00840096408980Viant Medical, LLCVIANT MEDICALHTO2020-09-03