DEVICE: AHTO (07613327061475)
Device Identifier (DI) Information
AHTO
0250070640
In Commercial Distribution
250-070-640
STRYKER CORPORATION
0250070640
In Commercial Distribution
250-070-640
STRYKER CORPORATION
Disposable Suction/Irrigator Tube Set, Dual Spike
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Surgical irrigation/aspiration tubing set | A collection of sterile, flexible, noninvasive, double-lumen tubing 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 field through one lumen, and provide aspiration (suction) through the other lumen (i.e., capable of both functions), during a surgical procedure (e.g., dental, laparoscopy). It may include associated items (e.g., clamps, valves, filters, spikes and connectors), and a manual pump for channelling between the irrigation source and the point of application. Some types may have additional tubing to assist gastric lavage. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HET | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) |
KQT | EVACUATOR, GASTRO-UROLOGY |
GCX | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K042454 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
aa993ebe-39e7-4bae-bd64-fd9a3b9c6ffb
February 07, 2019
4
September 23, 2016
February 07, 2019
4
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
37613327061476 | 6 | 07613327061475 | In Commercial Distribution | pack |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(866)624-4422
xx@xx.xx
xx@xx.xx